Appetite Hormones in Binge Eating Disorder

March 8, 2013 updated by: Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
This study investigates the hormones that the body produces in response to food intake and in response to stress, and the way that stress influences food intake. In particular, it compares the hormone levels and food intake of people with and without binge eating disorder. In order to find out how these appetite- and stress-related hormones are linked to brain activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which regions of the brain are most active during a food-related scenario.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objectives are to study appetite-related hormones regulating food intake under normal conditions and following a stressor in the morning and evening (when most binge episodes occur), to help reveal biological mechanisms in BED. We plan to enroll: 32 obese Ss with BED (16m, 16f), 32 obese Ss without BED (16m, 16f) and 32 normal-weight Ss without BED (16m, 16f). Height, weight, waist circumference, and body fat will be assessed during a first appointment. On two different days separated by at least a week, Ss will ingest a fixed liquid meal once in the morning and once in the evening. Appetite ratings and collections of blood and saliva to measure hormones will continue for 2 hours after the fixed meal. This will be followed on each day by a laboratory stress protocol (Socially Evaluated Cold Pressor Test; SECPT), and then consumption of an ad libitum meal 30 minutes later. On one day during the protocol, the participant will collect saliva using a swab immediately after waking and again at 08.00. In order to capture more naturalistic eating episodes, all Ss will additionally record food intake, rate appetite, and measure salivary cortisol before and after one evening meal, and one after-dinner snack (or after-dinner binge for BED Ss). On two additional days, we will use fMRI to assess brain activation in response to high-palatability food (HPF) relative to low-palatability food (LPF) or non-food (NF) visual cues following the SECPT and a control condition using warm water. On each day, following the fMRI scan, an ad libitum meal will be consumed.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Luke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI of 20-25 or 30-50
  • stable weight(± 4%) for at least 3 mo
  • premenopausal and have regular menstrual cycles (28 d ± 5), not be pregnant or lactating, and not be within 1 y of childbirth
  • must like pizza and be willing to consume it during the ad libitum meal

Exclusion Criteria:

  • significant medical or psychiatric conditions
  • current and past 3-mo use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (> 3 drinks/d)
  • vigorously exercise for more than 6 h/wk
  • left-handed, with known claustrophobia for a scanner enclosure, or have metal implants, non-removable metallic dental retainers, pacemakers, or permanent eyeliner or large tattoos that contain metallic pigment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese subjects with BED

Subjects who meet the BMI requirement for obesity (>30 kg/m^2) and the DSM requirements for binge eating disorder based on responses to validated questionnaires.

Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.
Procedure: Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Other Names:
  • Liquid meal replacement is Boost (Nestle Nutrition).
Behavioral: Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Behavioral: Test meal
Subjects are presented with an ad libitum buffet meal.
Experimental: Obese without BED

Subjects who meet the BMI requirement for obesity (>30 kg/m^2) but who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires.

Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.
Procedure: Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Other Names:
  • Liquid meal replacement is Boost (Nestle Nutrition).
Behavioral: Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Behavioral: Test meal
Subjects are presented with an ad libitum buffet meal.
Experimental: Normal-weight without BED

Subjects with BMI 20-25 kg/m^2 who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires.

Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.
Procedure: Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Other Names:
  • Liquid meal replacement is Boost (Nestle Nutrition).
Behavioral: Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Behavioral: Test meal
Subjects are presented with an ad libitum buffet meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test
Time Frame: Assessed at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00
Blood and saliva concentrations of hormones influencing appetite will be measured at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00. Appetite will additionally be rated at each assessment point. This will be followed by a cold pressor test, and then 30 min later by an ad libitum meal 30 min later, with blood and saliva measurements taken before and after completion of the meal.
Assessed at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol Awakening response
Time Frame: Assessed on one weekday morning during the 3-week participation period
On one weekday morning during the 3-week participation period, participants will take one saliva measurement on awakening and at 08.00 while still fasting. Awakening and 08.00 cortisol levels are expected to be higher in BED compared with nonBED Ss, and in obese nonBED compared with normal-weight nonBED Ss.
Assessed on one weekday morning during the 3-week participation period
Psychological Scales
Time Frame: During one initial consultation and on two subsequent visits at least 1 week apart
Various questionnaires will be administered to test relationships between outcomes (e.g., intake, hormone levels), and psychological constructs including depression, perceived stress, external and emotional eating and restraint, binge-eating behavior, and night eating. Outcomes will be correlated with scale scores, and scores will be compared between groups. Among other relationships, we anticipate positive correlations between binge eating score, ad libitum intake and ghrelin SECPT response. Psychological scores will be entered as covariates as appropriate.
During one initial consultation and on two subsequent visits at least 1 week apart
Body Weight, Body Composition and Gender
Time Frame: During one initial consultation and on two subsequent visits at least 1 week apart
Measurements will include height, weight, waist circumference, total body fat from BIA, and cross-sectional abdominal MRI to estimate central, visceral, and subcutaneous fat. Each adiposity index will be correlated with outcomes and compared between groups.
During one initial consultation and on two subsequent visits at least 1 week apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Obesity and Nutrition Research Center

Collaborators

Columbia University
St. Luke's-Roosevelt Hospital Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 11, 2013

Last Update Submitted That Met QC Criteria

March 8, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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